The present invention relates to a surgical instrument for a method of placing elongate elements in a patient, more particularly, but not exclusively in the field of obstetrics and gynaecology and more particularly the invention relates to an apparatus and method for the treatment of female urinary incontinence.
Female incontinence generally occurs due to deterioration of or damage to muscle tissue and ligaments in the pelvic region. This results in involuntary leakage of urine from the urethra due to lack of control of the patient""s pelvic muscles, particularly the urogenital diaphragm and pubo urethral ligaments. It has been found that the condition can be treated by creating some form of artificial ligament between the abdominal muscles and the urethra, the ligament passing behind the pubis.
The application is aware of two prior art patents which deal with similar subject matter to that of this invention, namely U.S. Pat. No. 5,112,344 (Petros) and U.S. Pat. No. 5,899,909 (Claren). U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive a filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vaginal and the rectus abdominis sheath in the anterior wall of the abdomen whereby it masses to each side of the urethra, adjusting the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element.
The Claren Patent, U.S. Pat. No. 5,899,909, also describes a surgical instrument and a method for treating female urinary incontinence. The instrument comprises a shank having a handle at one end thereof, and two curved needle-like elements which are connected at one end thereof each with one end of a tape intended to be implanted into the body. These elements can be connected one at a time with the shank at the other end thereof to form a curved end portion of the shank and are intended to be passed into the body via the vagina, each element being dimensioned to extend from the inside of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall. When practicing the method the tape is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and the vaginal wall. The tape is extended over the pubis and through the abdominal wall and is tightened. Then, the tape ends are cut at the abdominal wall, and the tape is left implanted in the body.
In its broadest form the invention provides a surgical instrument for use in placing an elongate element into a patient said instrument comprising:
an elongate shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and handle means formed on the other end thereof, the shaft including the handle means being of substantially uniform cross-section along its entire length such that the shaft may be passed into and through a patient, the internal passage being adapted to be used to introduce a said elongate element into a patient whilst the instrument is located in a patient in use.
In one preferred form of the invention there is provided a surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra extending over the back of the pubic bone, to the abdominal wall, said instrument comprising:
a generally arcuately curved tubular shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and handle attachment means formed on the other end thereof, the shaft being of substantially uniform cross-sectional diameter along its entire length;
a handle, non-rotatably connectable to the handle attachment means of the shaft;
a flexible threading element insertable into and through said internal passage from either end of said shaft at least when the handle is detached from the shaft and adapted to be used to draw one end of a said filamentary element through said internal passage.
According to another aspect of the invention there is provided a surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra extending over the back of the pubic bone, to the abdominal wall, said instrument comprising:
a generally arcuately curved tubular shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and handle attached means formed on the other end thereof;
a handle, non-rotatable to the shaft when connected thereto and further connectable to the handle attachment means of the shaft;
a flexible threading element insertable into and through said internal passage from either end of said shaft and adapted to be used to draw one end of a said filamentary element through said internal passage;
said tubular shaft being curved so that the shaft lies substantially in a single plane;
the cutting tip being formed having a transverse angle which lies at least substantially in a plane perpendicular to said single plane and at an acute angle to the shaft axis. The leading edge of the tip preferably lies on the radially inner side of said curved tubular shaft.
The acute angle is preferably between 20xc2x0 and 70xc2x0 and it is more probably approximately 45xc2x0. Preferably the leading end of the shaft is curved.
The cutting tip may be formed having two bevel faces, inclined to each other at an acute angle. The two level faces preferably intersect along a line which is perpendicular to the shaft axis.
In one arrangement the handle attachment means comprises screw threads formed on the outer surface of the shaft. Preferably the shaft tapers divergently towards the handle attachment means so as to form a smooth transition between a cylindrical portion of said shaft and said handle attachment means.
An interior surface of said internal passage at or towards said other end of the shaft may include one or more notch or detent formation with which said handle will engage to provide for said non-rotatable connection.
Said handle preferably comprises a hand engageable portion which is significantly wider than said shaft and a shaft portion adapted to be axially aligned with said other end of the tubular shaft when the handle and the tubular shaft are operatively connected. Said shaft portion may have a distal end of reduced diameter adapted to be inserted into the internal passage of the shaft. Preferably the handle includes an annular flange on said shaft portion adapted to engage against said other end of said tubular shaft, and a union nut captively held on said shaft portion between the annular flange and the handle portion and slidable on said shaft portion, said union nut adapted to engage with the screw threads formed on the tubular shaft in order to hold the tubular shaft and handle together.
The tubular shaft preferably has a generally arcuate portion towards the end thereof remote from the handle end thereof, and a generally straight portion towards the handle end thereof.
The tubular shaft may have a series of apertures passing through the wall thereof between the internal passage and the exterior of the shaft, said apertures being spaced apart along the length of the shaft.
According to a further aspect of the invention there is provided a surgical instrument for use in placing a filamentary element into a female patient to form a sling or loop between an anterior surface of the vaginal wall, around the back of the pubic bone to the outside of the abdominal wall, said instrument comprising a generally curved tubular shaft defining an internal passage, said shaft having at least one aperture passing through the wall thereof between the internal passage and exterior of the shaft.
Preferably there are a series of such apertures spaced apart along the length of the shaft. Preferably the apertures are located on the convex side of the shaft. The shaft preferably has a cutting tip formed on one end thereof and handle attachment means on the other end thereof, and the shaft has a generally arcuate portion towards the end thereof remote from the handle end, and a generally straight portion towards the handle end, the apertures being located at least in the generally arcuate portion.
According to a further aspect of the invention there is provided a method of introducing a filamentary element into a female patient so as to form a sling or loop extending around the urethra to an anterior surface of the abdominal wall, said method including the steps of:
a) inserting a generally arcuately curved shaft, having a longitudinally extending internal passage, into the patient through the anterior surface of the vaginal wall, so as to pass on one side of the urethra between the pubis and the bladder and pass out of the patient through the abdominal wall;
b) passing a threading element along the internal passage from one or other end thereof so that the distal end of the threading element passes out of the remote end of the shaft;
c) attaching a filamentary element to the distal end of the threading element and drawing the filamentary element through the shaft with the threading element;
d) withdrawing the shaft from the patient whilst leaving the filamentary element in position in the patient;
e) inserting the shaft into the patient through the anterior surface of the vaginal wall, so as to pass on the other side of the urethra between the pubis and the bladder and pass out of the patient through the abdominal wall;
f) repeating steps b), c) and d) to draw the filamentary element through the shaft; and
g) withdrawing the shaft from the patient whilst leaving the filamentary element in position thereby forming a loop which extends around the urethra to the anterior surface the abdominal wall on opposite sides of the urethra.
The shaft may either be tubular or U-shaped in cross section having a longitudinal slot or groove extending along the length thereof.
The aforementioned method may be performed using either a single incision or a pair of incisions. The two incisions method includes forming a pair of para-urethral incisions are made at or very near each anterior sulcus of the vagina. A tunnel is created by blunt dissection between the urethra and the vaginal wall, extending from each vaginal incision. Prior to conducting step (e) the end of the filamentary element adjacent the vagina is passed through that tunnel and out of the second of the two incisions. Step (f) is conducted through the second of the two incisions.
It will be appreciated that the process allows the threading element to be inserted into the hollow shaft from either end of the shaft, as desired.
Preferably the shaft is provided with a detachable handle, the shaft being of substantially uniform outer dimensions along its entire length thereby allowing the shaft to be withdrawn from the patient, once the handle has been removed, from the outside of the abdominal wall.
These and further features of the invention will be made apparent from the description of an embodiment thereof given below by way of example. In the description reference is made to the accompanying drawings, but the specific features shown in the drawings should not be construed as limiting on the invention.